GUEST COLUMNISTS

• Wish SUS Cost Less? Survey Says Your Peers Do, Too

  BioPlan Associates 21st Annual Report found biopharma companies want lower cost single-use system options over any other new product development area.

• Pharmaceutical Continuous Manufacturing: Content Uniformity With PAT And RTR

  Content uniformity is one of the most important release criteria for solid dosage forms. In continuous manufacturing, what process analytical technologies (PAT) are available to measure and assure content uniformity as part of a real time release (RTR) strategy?

• EMA Issues New Draft Guideline: Chemistry Of Active Substances

  The European Medicines Agency (EMA) has issued a new draft guideline to set out the type of information required for the manufacture and control of active substances used in a medicinal product. The public consultation period ends Jan. 31, 2025.

• August 2024 — CDMO Opportunities And Threats Report

  Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

• Capacity, AI Driving Single-use Bioprocess Probe And Sensor Uptake

  Disposable probes and sensors offer advantages over their reusable counterparts, especially as industry moves toward flexible, scalable production models.

• A Year In, Sanofi's Journey With Plai AI Is Aiding Quality Decisions

  Sanofi has been a vocal of advocate of AI/ML for years. Here's how it's using technology to facilitate the audit process and get to the bottom of deviations faster.

• Great siRNA Science Or Savvy Business Acumen? You Need Both

  Silence Therapeutics has two wholly owned siRNA therapies now in clinical trials and one partnered program with AstraZeneca. Silence's CEO discusses the need for good science, making smart business decisions, and cultivating partnerships.

• Luxturna Maker Spark Therapeutics' Flexible Platform Approach

  The company proved the concept by bringing to market its AAV-based gene therapy for an inherited form of vision loss.